Request Medtronic rhBMP-2 Data
Medtronic has provided individual participant-level data (IPD) for each of their 17 clinical trials evaluating the efficacy or safety of rhBMP-2. The data are presented in a range of separate SAS-format data files for each trial according to the types of outcomes reported. Thirteen trials were randomized, controlled trials and four were single arm studies.
Medtronic also provided the following documentation, and any revision documents, for the 17 trials (please note- not all documents are available for each trial):
- Data Dictionary
- Trial Protocol
- Imaging Protocol
- Statistic Considerations Redacted
- Descriptions of derived endpoint variables
- Clinical Report Form
- Adverse Events Form
- Pre-Market approcal clinical study report redacted (where relevant)
- Pre-Market approval PAS final report redacted (where relevant)
- Final Report Redacted
- Clinical Study Report
Instructions for Submitting an Application (all steps must be completed)
- Click here to submit your registration information. The following information is required:
- Applicant’s name, degree, SCOPUS ID (if applicable), employer, and contact information
- Project funding
- Certification of Institutional Review Board (IRB)/Ethics Board approval or waiver
- Name, degree, SCOPUS ID (if applicable), and employer for all project team members
- Click here to complete the Data Use Agreement Training
- Email the following items as attachments in one email to email@example.com:
- Conflict of Interest statement for all team members (form available via Step 1)
- IRB/Ethics Board Documentation for one of the following:
- Certificate of IRB/Ethics Board approval
- Notification of waiver of full IRB/Ethics Board review/approval
- Signed Data Use Agreement (click here for DUA)
- Research Study Protocol (which includes project specific aims, main and secondary outcomes of interest and analysis plan, and timeline). Data can be used only for the scientific purposes that are described in the proposal (click here for a sample proposal).*
An email confirmation will be sent once applications are received. Applicants will be notified if further materials are needed. Once completed application is submitted, please allow 3-4 weeks for data delivery.**
*Please note: For those who receive the data- protocols, name of PI, institution, and name of project will be posted on the YODA Web site.
**Please note: YODA Project does not provide any technical or statistical support.
Data Release Policy
Click here for the policy
This policy was informed by the following:
- Recommendations from the YODA Project Steering Committee and other independent experts (made in the context of a conference hosted by Yale University in June 2012);
- Additional communications with these experts and others;
- Comments received during a public comment period; and
- The YODA Project team’s review of the literature and policies from other bodies engaged in clinical trial data sharing.
We expect the process by which we finalize the policy for data release to be iterative and informed by on-going experiences with data requesters and users.